Correction of higher order aberrations in intraocular lenses

ABSTRACT

In one aspect, the present invention provides a method of designing an intraocular lens (IOL) to address variations of at least one ocular parameter in a population of patient eyes. The method can include establishing at least one eye model in which the ocular parameter can be varied over a range exhibited by the population. The eye model can be employed to evaluate a plurality of IOL designs in correcting visual acuity for eyes in the patient population. An IOL design that provides a best fit for visual performance over at least a portion of the parameter range can then be selected.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Continuation (CON) of U.S. application Ser. No.12/971,125 filed Dec. 17, 2010, which is a Continuation (CON) of U.S.application Ser. No. 11/435,905, filed May 17, 2006, now U.S. Pat. No.7,879,089, priority of which is claimed under 35 U.S.C. §120, thecontents of both of which are incorporated herein by reference.

BACKGROUND

The present invention relates generally to methods of designingophthalmic lenses, and more particularly to such methods that take intoaccount variations of ocular parameters within a population.

Intraocular lenses (IOLs) are routinely implanted in patients' eyesduring cataract surgery to replace the natural crystalline lens. Suchlenses are typically designed by employing simplified eye models that donot necessarily provide an accurate representation of the human eyeanatomy. In some cases, a relatively accurate eye model representing anaverage human eye is established for the design process. However, suchan average eye model cannot be utilized to consider variations inperformance of the lens across a population of patients whose eyes canexhibit differing ocular parameters.

Accordingly, there is a need for better methods for designing ophthalmiclenses, and in particular IOLs.

SUMMARY

The present invention is generally directed to methods of designingintraocular lenses (IOLs) that account for variations of one or moreocular parameters, such as, ocular axial length or corneal asphericity,within a population of patient eyes for which the IOL is intended. Byway of example, such a method can arrive at a final IOL design byconsidering visual performance (e.g., visual acuity and/or contrastsensitivity) achieved by a plurality of IOL designs—generated, e.g., byvarying a lens design parameter—in a model eye in which at least oneocular parameter can be varied. In some cases, the IOL design thatprovides the best fit for visual performance over at least a portion ofan ocular parameter range exhibited by the population is selected. Thebest fit visual performance can be determined, for example, byevaluating the average of weighted visual performance for each IOLdesign across the ocular parameter range. The weighting of the visualperformance can be based, e.g., on the distribution of the ocularparameter values over the population.

In one aspect, the invention provides a method of designing an IOL toaddress variations of at least one ocular parameter in a population ofpatient eyes. The method can include establishing at least one eye modelin which the ocular parameter can be varied over a range exhibited bythe population. The eye model can be employed to evaluate a plurality ofIOL designs in correcting visual performance of eyes in the patientpopulation. An IOL design that provides a best fit for visualperformance (e.g., visual acuity or contrast sensitivity) over at leasta portion of the range exhibited by the population can then be selected.By way of example, in this manner, a series of IOL designs can beselected such that each individual design provides the best visualperformance for a portion of the population of patient eyes.

In a related aspect, the method calls for applying a weighting functionto visual performance exhibited by the IOL designs. The weightingfunction can be based, e.g., on distribution of the ocular parametervalues within the population. For example, the visual performanceexhibited by the eye model at a more probable value of the ocularparameter can be given a greater weight than that at a less probablevalue. The best fit for visual performance can be determined as anoptimal value of the weighted visual acuity among the IOL designs.

In a related aspect, the IOL designs can be generated by varying atleast one lens design parameter. By way of example, the lens designparameter can be a conic constant of an aspherical surface of the lens,two conic constants associated with a toric surface of the lens, anapodization function associated with step heights at zone boundaries ofa diffractive pattern disposed on a lens surface, or any other lensparameter of interest.

In a related aspect, the visual performance associated with an eye modelincorporating an IOL design can be obtained by determining a modulationtransfer function at the retina of the eye model. By way of example, themodulation transfer function can be calculated theoretically byemploying ray-tracing techniques.

In another aspect, the ocular parameter can include, for example, ocularaxial length, corneal asphericity (e.g., a conic constant characterizingthe corneal asphericity), corneal radius and/or ocular anterior chamberlength.

In other aspects, a method of designing an IOL is disclosed thatincludes generating a human eye model in which at least one ocularbiometric parameter can be varied. The method further calls forevaluating the optical performance of a plurality of IOL designs byincorporating the designs in the eye model and varying the ocularparameter over at least a portion of a range exhibited by eyes in apatient population. At least one of the IOL designs that provides anoptimal performance can then be selected.

The ocular parameter can comprise, for example, any of the cornealradius, corneal sphericity, anterior chamber depth or ocular axiallength. Further, the IOL designs can be generated by varying at leastone lens design parameter, e.g., by employing a Monte Carlo simulation.Some examples of such lens design parameters include, withoutlimitation, a conic constant of an aspherical lens surface, two conicconstants associated with a toric lens surface or an apodizationfunction associated with step heights at zone boundaries of adiffractive pattern disposed on a lens surface.

In a related aspect, the optical performance of an IOL design can beevaluated by employing the eye model to determine an average visualperformance (e.g., visual acuity) provided by that design over theocular parameter range. By way of example, the visual performanceexhibited by an IOL design at a given value of the ocular parameter canbe determined by calculating a modulation transfer function at theretina of the eye model incorporating the design. The visual performancevalues calculated for a number of different values of the ocularparameter within a range of interest can then be averaged to generate anaverage visual performance. In some cases, the evaluation of the opticalperformance of an IOL design is based on a weighted average visualacuity determined for that design, e.g., in accordance with probabilitydistribution of the values of the ocular parameter over the rangeexhibited by the population. The IOL exhibiting the greatest weightedvisual performance can then be identified as the one providing anoptimal performance.

In another aspect, a method of designing a family of intraocular lenses(IOLs) is disclosed that includes establishing at least one eye model inwhich at least one ocular parameter can be varied over a range exhibitedby a population of patients. The eye model can then be employed toevaluate a plurality of IOL designs for visual performance for eyes inthe patient population. At least two of the IOL designs can be selectedsuch that one design provides the best fit visual performance (e.g.,based on visual acuity and/or image contrast) for one portion of thepopulation and the other provides the best fit visual performance foranother portion of the population. The ocular parameter can be, forexample, corneal radius, corneal asphericity, anterior chamber depth, oraxial length. By way of example, in one embodiment, three IOL designscan be selected, each for one portion of a population, such that one IOLdesign exhibits an spherical aberration of about −0.1 microns, while theother two exhibit, respectively, spherical aberrations of about −0.2 andabout −0.3 microns.

In another aspect, the invention provides a method of modeling visualperformance of an ophthalmic lens, e.g., an IOL, which includesestablishing a model eye that incorporates the ophthalmic lens anddetermining a modulation transfer function (MTF) at a retinal plane ofthat model eye. At least one MTF value corresponding to a low spatialfrequency can then be utilized to evaluate a contrast sensitivity ofthat model eye. The low spatial frequency can be, e.g., a spatialfrequency less than about 60 lp/mm (˜18 cycles/degree or 20/33 letteracuity). By way of example, the low spatial frequency can be in a rangeof about 5 to about 60 lp/mm (˜1.5 to 18 cycles/degree). Further, atleast one MTF value corresponding to a high spatial frequency can beutilized to evaluate a visual acuity of the model eye. The high spatialfrequency can be, e.g., a spatial frequency greater than about 60 lp/mm(˜18 cycles/degree). For example, the high spatial frequency can be in arange of about 60 lp/mm to about 100 lp/mm (˜18 to 30 cycles/degree).

In another aspect, a method of modeling visual performance of anophthalmic lens, e.g., an IOL, is disclosed that includes establishing amodel eye that incorporates the ophthalmic lens and determining amodulation transfer function (MTF) at a retinal plane of that model eye.At least one MTF value corresponding to a high spatial frequency canthen be utilized to evaluate a visual acuity of the model eye. The highspatial frequency can be, e.g., a frequency greater than about 60 lp/mm(˜18 cycles/degree). For example, the high spatial frequency can be in arange of about 60 to about 100 lp/mm (˜18 to 30 cycles/degree).

In yet another aspect, estimates of manufacturing tolerance associatedwith one or more lens characteristics can be incorporated in the IOLdesign. This allows the visual performance calculations to take intoaccount variations of certain lens properties that can occur duringmanufacturing. Some examples of lens characteristics, which can besubject to statistical variations due to manufacturing tolerances,include irregularities imparted to one or more lens surfaces, the radiusof one or more lens surfaces, the lens thickness, or the degree ofasphericity exhibited by one or more lens surfaces.

In another aspect, a method is disclosed for providing an IOL forimplantation in a patient's eye characterized by an ocular parameterwithin a range exhibited by eyes of patients in a population. The methodincludes providing a plurality of IOLs having variations in at least onelens design parameter, and selecting of the IOLs that provides a bestfit for visual performance over at least a portion of the ocularparameter range for implantation in the patient's eye.

In a related aspect, in the above method, the selection of the IOLfurther comprises determining visual performance exhibited by each IOLfor a plurality of ocular parameter values within the range of valuesexhibited by the eyes of patients in the population. A weighted averagevisual performance for each IOL based on a probability distribution ofthe ocular parameter in the population can then be generated, and thebest fit for visual performance can be identified as a maximum value ofthe weighted average visual performance across the lens designs.

Some examples of ocular parameters whose variations can be considered inthe above method of providing an IOL include, without limitation,corneal radius, corneal asphericity, anterior chamber depth, ocularaxial length, and a deviation of line of sight from an optical axis ofthe eye.

Further understanding of the invention can be obtained by reference tothe following detailed description in conjunction with the associateddrawings, which are briefly described below:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flow chart depicting various steps in an exemplaryembodiment of a method according to the teachings of the invention fordesigning an IOL,

FIG. 2 is a schematic cross-sectional view of a hypothetical diffractivelens whose performance across a population of interest can be evaluatedby incorporation in an eye model and varying selected ocular parametersof the model,

FIG. 3A shows a plurality of MTFs calculated in an exemplary embodimentof a method of the invention for a plurality of eye models characterizedby different corneal radii in which a hypothetical IOL design wasincorporated,

FIG. 3B shows a plurality of MTFs calculated in an exemplary embodimentof a method of the invention for a plurality of eye models characterizedby different corneal radii in which another (reference) hypothetical IOLwas incorporated,

FIG. 4A shows a plurality of MTFs calculated in an exemplary embodimentof a method of the invention for a plurality of eye models characterizedby different values of corneal sphericity, in which a hypothetical IOLdesign was incorporated,

FIG. 4B shows a plurality of MTFs calculated in an exemplary embodimentof a method of the invention for a plurality of eye models characterizedby different values of corneal sphericity, in which another (reference)hypothetical IOL was incorporated,

FIG. 5A shows a plurality of MTFs calculated in an exemplary embodimentof a method of the invention for a plurality of eye models characterizedby different values of anterior chamber depth, in which a hypotheticalIOL design was incorporated,

FIG. 5B shows a plurality of MTFs calculated in an exemplary embodimentof a method of the invention for a plurality of eye models characterizedby different values of anterior chamber depth, in which a different(reference) hypothetical IOL was incorporated,

FIG. 6 presents a plurality of MTFs calculated for eye models, in one ofwhich a reference IOL and in the other a hypothetical IOL design wereincorporated, as a function of different decentration values of theIOLs,

FIG. 7 presents a plurality of MTFs calculated for eye models, in one ofwhich a reference IOL and in the other a hypothetical IOL design wereincorporated, as a function of different tilt values of the IOLs,

FIG. 8 presents a plurality of MTFs calculated for eye models having ahypothetical aspheric/toric IOL design and a reference spherical/toricIOL for three rotation angles of the lenses,

FIG. 9A shows exemplary MTF calculations performed in an embodiment of amethod of the invention for eye models having a hypothetical IOL designfor a number of different spherical refractive errors,

FIG. 9B shows exemplary MTF calculations performed in an embodiment of amethod of the invention for eye models having a reference IOL for anumber of different spherical refractive errors,

FIG. 10 presents MTFs computed for eye models having a reference IOL anda hypothetical design IOL for a number of different cylindricalrefractive errors,

FIG. 11 shows the results of simulations of averaged MTF for 200 eyemodels, characterized by different biometric parameters and/ormisalignment and refractive errors, where each eye model was consideredwith six different hypothetical IOLs,

FIG. 12 graphically depicts a change in the MTF associated with eachsimulated eye model in FIG. 11, in response to replacing a sphericalreference lens in the model with one of a number of different asphericallenses,

FIG. 13 graphically depicts the distribution of calculated MTF valuescorresponding to different simulated eye models in which a plurality ofIOL design options were incorporated,

FIG. 14 schematically depicts an offset between a line of sightassociated with a model eye and an optical axis of an IOL incorporatedin the model eye,

FIG. 15A presents a plurality of polychromatic MTFs calculated for amodel eye in which an aspherical lens is incorporated for a zero tiltand a 5-degree tilt of the optical axis of the lens relative to the lineof sight of the eye,

FIG. 15B presents a plurality of polychromatic MTFs calculated for amodel eye in which a spherical lens is incorporated for a zero tilt anda 5-degree tilt of the optical axis of the lens relative to the line ofsight of the eye,

FIG. 16A presents a plurality of polychromatic MTFs calculated for amodel eye in which an aspherical lens is incorporated for a zero tiltand decentration and a 5-degree tilt and a 0.5-mm decentration of theoptical axis of the lens relative to the line of sight of the eye, and

FIG. 16B presents a plurality of polychromatic MTFs calculated for amodel eye in which a spherical lens is incorporated for a zero tilt anddecentration and a 5-degree tilt and a 0.5-mm decentration of theoptical axis of the lens relative to the line of sight of the eye.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention generally provides methods for designingophthalmic lenses (e.g., IOLs) by simulating the performance of aplurality of lenses in model eyes characterized by different values ofselected ocular parameters based on variations of those parametersexhibited in a population of patient eyes. In the embodiments thatfollow, the salient features of various aspects of the invention arediscussed in connection with intraocular lenses. However, the teachingsof the invention can also be applied to other ophthalmic lenses, such ascontact lenses. The term “intraocular lens” and its abbreviation “IOL”are used herein interchangeably to describe lenses that are implantedinto the interior of the eye to either replace the eye's natural lens orto otherwise augment vision regardless of whether or not the naturallens is removed. Intracorneal lenses and phakic lenses are examples oflenses that may be implanted into the eye without removal of the naturallens.

With reference to a flow chart of FIG. 1, in one embodiment of a methodfor designing an intraocular lens (IOL), in an initial step 1, an eyemodel is established in which at least one ocular parameter (e.g.,corneal radius or sphericity) can be varied. In many embodiments, theeye model is a theoretical model that facilitates varying one or more ofthe ocular parameters, though a physical eye model can also be utilized.The eye model can then be employed to evaluate a plurality of IOLdesigns in correcting visual performance for eyes in a patientpopulation of interest (step 2). Based on the evaluations of the IOLdesigns, in step 3, at least one of the designs can be selected thatprovides a best fit for visual performance over at least a portion of arange (or preferably the entire range) of values exhibited for thatocular parameter in that patient population.

In many embodiments, the optical performance of each IOL design can beevaluated by calculating a modulation transfer function (MTF) associatedwith the eye model in which that IOL design is incorporated. As known inthe art, an MTF provides a quantitative measure of image contrastexhibited by an optical system, e.g., an eye model comprising an IOL.More specifically, the MTF of an imaging system can be defined as aratio of a contrast associated with an image of an object formed by theoptical system relative to a contrast associated with the object.

The human visual system utilizes most spatial frequencies resolvable byneural sampling. Thus, in many embodiments, the MTF values ranging fromlow (e.g., 10 lp/mm, corresponding to about 20/200 visual acuity) tohigh (e.g., 100 lp/mm, corresponding to about 20/20 visual acuity) areaveraged to obtain measure of an expected optical performance of an IOLdesign implanted in a human eye.

In the exemplary embodiments discussed below, an average MTF is employedas a merit function to determine an optimal focal plane and to assessthe optical quality of a particular hypothetical eye model in MonteCarlo simulations.

The Monte Carlo analysis can be configured to simulate randomvariability associated with values of various ocular parameters amongdifferent patients. By way of example, human eyes exhibit variablecorneal power, corneal spherical aberration, anterior chamber depth, andaxial length. Further, the natural crystalline lens, and/or an implantedIOL, can have various amounts of rotation, decentration and/or tilt,e.g., relative to an optical axis of the eye. The variations arerandomly, and generally normally, distributed. In many embodiments, theMonte Carlo analysis selects values from a normal probabilitydistribution associated with one or more of these variables (e.g., ajoint probability distribution corresponding to a plurality ofvariables) to generate a plurality of hypothetical human eyes belongingto a population of interest. The optical quality of each eye model asindicated, for example, by an average MTF, can then be computed. In someembodiments, the eye model having the best average MTF can be chosen asthe most suitable design for that population. Further, the MTF valuescan be aggregated to provide statistics, such as mean, standarddeviation, 10 percentile, 50 percentile and 90 percentile.

In addition to biometric parameters, variations due to other factors,such as misalignment errors (e.g., decentration, tilt and/or rotation)and defocus, can also be considered in simulating the opticalperformance of a plurality of IOLs.

To further illustrate various aspects of the invention, the opticalperformance of each of a plurality of hypothetical and exemplary lensdesigns was evaluated by varying selected ocular parameters of an eyemodel in which the lens design was incorporated. With reference to FIG.2, each lens was assumed to include an optic 18 having an anterioroptical surface 20 and a posterior optical surface 22 disposed about anoptical axis 24. The anterior surface includes a diffraction pattern 26formed of a plurality of diffractive zones 26 a, which are separatedfrom one another by steps whose heights decrease as their distances fromthe optical axis increase. By way of example, the step heights can bedefined in accordance with the following relation:

$\begin{matrix}{{{Step}\mspace{14mu} {height}} = {\frac{p\; \lambda}{n_{2} - n_{1}}f_{apodize}}} & {{Eq}.\mspace{14mu} (1)}\end{matrix}$

wherein,

p is a phase height,

λ is a design wavelength (e.g., 550 nm),

n₂ is the refractive index of the material forming the lens, and

n₁ is the index of refraction of the medium surrounding the lens,

f_(apodize) denotes an apodization function.

A variety of apodization functions can be employed. For example, in someembodiments, the apodization function is defined in accordance with thefollowing relation:

$\begin{matrix}{{f_{apodize} = {1 - \left\{ \frac{\left( {r_{i} - r_{i\; n}} \right)}{\left( {r_{out} - r_{i\; n}} \right)} \right\}^{\exp}}},{r_{i\; n} \leq r_{i} \leq r_{out}}} & {{Eq}.\mspace{14mu} (4)}\end{matrix}$

wherein

r_(i) denotes the distance of each radial zone boundary from theintersection of the optical axis with the surface,

r_(in) denotes the inner boundary of the apodization zone,

r_(out) denotes the outer boundary of the apodization zone, and

exp denotes an exponent to obtain a desired reduction in the stepheights. Further details regarding apodization of the step heights canbe found, e.g., in U.S. Pat. No. 5,699,142, which is herein incorporatedby reference.

Moreover, a base profile of the anterior surface has an aspherical baseprofile characterized by a selected degree of asphericity while theposterior surface exhibits a selected degree of toricity. A referencehypothetical design was also considered in which the anterior surface isspherical (i.e., it lacks asphericity). The various structuralparameters of these hypothetical designs (i.e., anterior surface radius(ASR), anterior surface asphericity (ASC), posterior surface radius atone meridian (BSR1), posterior surface radius at another steepermeridian (BSR2), the center thickness (CT), power, and toricity) aresummarized in Table 1 below:

TABLE 1 ASR BSR1 BSR2 Power Design (mm) ASC (mm) (mm) CT (D) Toricity #120.74 −13.44 −22.33 −19.35 0.646 21 T3 (1.5) #2 20.74 −20.44 −22.33−19.35 0.646 21 T3 (1.5) #3 20.74 −28.51 −22.33 −19.35 0.646 21 T3 (1.5)#4 20.74 −37.99 −22.33 −19.35 0.646 21 T3 (1.5) #5 20.74 −47.36 −22.33−19.35 0.646 21 T3 (1.5) Reference 13.50 0 −50.10 −37.14 0.646 21 T3(1.5)

For the purposes of this illustration, the aforementioned biometric,misalignment and refractive error parameters were considered asindependent and uncorrelated variables in a joint statisticaldistribution. For each simulation run, different values of theseparameters were chosen randomly and independently so as to construct aneye model that would simulate an individual arbitrary eye in the generalpopulation. The optical performance of such an eye model with each ofthe above hypothetical IOL designs was evaluated by calculating the MTF.An optical design software marketed as Zemax® (version Mar. 4, 2003,Zemax Development Corporation, San Diego, Calif.) was utilized tocalculate the MTF. This process of random selection and optical modelingwas iterated 200 times, to provide statistics regarding performance ofeach design across the population. It should be understood that thesesimulations are presented only for illustrative purposes and are notintended to limit the scope of the invention. For example, in otherembodiments, the number of iterations can be much larger than 200 (orless than 200).

By way of example, in the above simulations, the corneal radius wasassumed to be normally distributed above an average value of about 7.72mm with a standard deviation of +/−0.28 mm. Further, the values ofcorneal asphericity (conic constant) were selected from a normaldistribution having an average value of −0.183 and a standard deviationof +/−0.160. The anterior chamber depth was assumed to be distributedabout an average value of 4.60 mm with a standard deviation of +/−0.30mm.

By way of example, FIG. 3A shows a plurality of MTFs calculated for eyemodels characterized by five different corneal radii (i.e., 7.16 mm (−2SD (standard deviation)), 7.44 (−1 SD), 7.72 mm (0 SD), 8.00 (+1 SD) and8.28 (+2 SD)), in which the above hypothetical IOL identified as Design#3 was incorporated. A corneal asphericity of −0.183 was employed forall the eye models. Moreover, FIG. 3B presents respective MTFs exhibitedby the same eye models, in which the above hypothetical IOL designatedas reference was incorporated. The calculations were performed byutilizing a 6.0 mm entrance pupil. These calculations show that theperformance of the IOL (design #3) having an aspherical anterior surfaceis more susceptible to variations in the corneal radius than that of thereference lens that lacks such asphericity.

As noted above, the corneal asphericity (typically expressed as conicconstant) is another parameter that was varied in the illustrative MonteCarlo simulations. A number of studies show that the distributions ofcorneal sphericity typically follow bell-curved shapes. A small portionof corneas are substantially aberration-free (characterized by a conicconstant of 0.5) and a small portion are spherical (characterized by aconic constant of 0). Most anterior corneas exhibit a corneal sphericitythat lies within one standard deviation of 0.16 about an average valueof −0.183. In other words, the average spherical aberration exhibited bya cornea within the general population is about 0.242 microns with astandard deviation of about 0.086 microns.

By way of example, FIG. 4A shows the MTFs calculated for eye modelscharacterized by five different values of corneal asphericity (i.e.,−0.503 (−2 SD), −0.343 (−1 SD), −0.183 (0 SD), −0.023 (+1 SD) and +0.137(+2 SD)), in which the above hypothetical IOL identified as Design #3was incorporated. A constant corneal radius of 7.72 mm was selected foreach eye model. FIG. 4B shows similarly calculated MTFs for the aboveeye models, in which the above hypothetical IOL designated as referencewas incorporated. The calculations presented in FIGS. 4A and 4B wereperformed for a 6.0 mm entrance pupil (5.2 mm at IOL plane).

The above simulations of the performance of a hypothetical asphericaland a hypothetical spherical lens as a function of the cornealasphericity show that the aspherical lens performs better than thespherical lens for a variety of corneal asphericities except for anaberration-free cornea. However, only a small percentage of the eyes inthe general population exhibit an aberration-free cornea (about 6%), andeven for such eyes, the performance of the aspherical lens is reasonablygood.

The anterior chamber depth, defined as the distance between the anteriorcorneal surface and the anterior lens surface, is another parameterwhose variations in a population can be considered in simulating theperformance of a plurality of IOLs. By way of example, FIG. 5A presentsa plurality of MTFs calculated for eye models characterized by thefollowing values of anterior chamber depth, in which the abovehypothetical IOL identified as Design #3 was incorporated: 4.0 mm (−2SD), 4.3 mm (−1 SD), 4.6 mm (0 SD), 4.9 mm (+1 SD), and 5.2 mm (+2 SD).To compare the performance of the Design #3 lens with that of thereference lens as a function of variations in the anterior chamberdepth, similar MTFs were computed for the above eye models in which thereference lens was incorporated, as shown in FIG. 5B. For both sets ofcalculations, a 6.0 mm pupil was employed.

These simulations indicate that the optical performances of the two IOLs(aspherical and spherical) are less susceptible to variations inanterior chamber depth than in corneal asphericity and/or radius.Although a deviation of an implanted IOL's position at an anteriorchamber depth from its intended design position can theoretically affectthe residual spherical aberration and astigmatic error, the abovecalculations indicate that such residual errors can be quite limited inpractice.

Other parameters that can affect the optical performance of a lensinclude misalignment effects, such as decentration, tilt and rotation. Alens placed in the human eye can be subject to these misalignmentsrelative to the cornea. For example, the performance of an asphericallens can be adversely affected due to decentration and tilt. Further,the performance of a toric lens can be susceptible to lens rotation,e.g., the lens rotation can cause astigmatic error. By way of example,FIG. 6 presents MTFs calculated for model eyes, in one of which theabove hypothetical aspherical lens designated as Design #3 and in theother the above hypothetical spherical reference lens were incorporated,as a function of the following decentration values: 0.0 mm, 0.25 mm and0.5 mm. The calculations were performed for a 6.0 mm entrance pupil (5.2mm at the IOL plane). These simulations indicate that the asphericallens is more susceptible to decentration than the spherical lens.However, even with a 0.5 mm decentration, the aspherical lens performsbetter than the spherical lens.

By way of further illustration, similar MTF calculations were performedon the two aforementioned aspherical and spherical lenses (i.e., Design#3 and reference) for the following tilt angles (at a pupil size of 6.0mm): 0, 2.5 and 5. These calculations, which are presented in FIG. 7,indicate that performance of the aspherical lens is more susceptible tothe lens tilt than that of the spherical lens. However, the asphericallens outperforms the spheric lens for all of the tilt angles.

The lens rotation within the eye can also affect its opticalperformance, e.g., by introducing residual astigmatism. By way ofexample, FIG. 8 presents a plurality of MTFs calculated for model eyeshaving the above hypothetical aspheric/toric Design #3 lens as well asthe spherical/toric reference lens for the following lens rotationsangles (at a pupil size of 6.0 mm): 0°, 2.5° and 5°. These simulationsindicate that the aspherical lens generally performs better than thespherical lens. In particular, the images generated by the asphericallens exhibit significantly higher contrast over a wide range of spatialfrequencies, even under a considerable lens rotation of 5°.

Refractive errors, which can give rise to defocus, constitute anotherset of parameters that can be utilized in simulating the opticalperformance of IOLs. For example, with current surgical techniques,spherical and/or cylindrical refractive errors of the order of +/−¼ Dcan occur. FIGS. 9A and 9B show, respectively, exemplary MTFcalculations performed for model eyes with the above Design #3 as wellas the reference hypothetical lens for the following sphericalrefractive errors: 0 D, ±⅛ D, and ±¼ D (a pupil size of 6.0 mm wasassumed). These calculations indicate that the performance of theaspherical lens can be more susceptible to spherical refractive errors.However, when considering the absolute magnitudes of modulationcontrasts, the aspherical lens performs better up to a defocus of about¼ D.

By way of further examples, FIG. 10 presents MTFs computed for modeleyes having the above Design #3 lens and the reference hypothetical lensas a function of the following cylindrical refractive errors (at a pupilsize of 6.0 mm): 0 D, ±⅛, and ±¼ D). These simulations indicate thatcylindrical refractive errors cause similar MTF drops for the sphericaland the aspherical lenses. However, even with a ¼ D cylindrical error,the aspherical lens exhibits a substantially greater MTF relative tothat exhibited by the spherical lens with no cylindrical error. Itshould be noted that misalignments due to lens rotation, which werediscussed above, can also induce residual cylindrical errors. However,the lens rotation can induce higher-order aberrations, as well.

Another parameter that can play a role in the optical performance of anIOL is the effective location of that IOL in the eye. Hence, in someembodiments of the invention, variations in the location of the 2^(nd)principal plane of an implanted IOL are simulated to take into accountrefractive errors that such variations can induce.

FIG. 11 shows the results of simulations of 200 eye models,characterized by different biometric parameters and/or misalignment andrefractive errors, with each of the above hypothetical IOLs (Table 1).The MTF for each simulation is presented as a data point. The averageMTF, the 10, 50 and 90 percentiles, as well as standard deviation (SD)and +/−2 SD deviations from the mean are presented in Table 2 below:

TABLE 2 Mean − 10% 50% 90% Mean Std 2 * SD Mean + 2 * SD Design #1 0.3030.243 0.189 0.244 0.047 0.149 0.339 Design #2 0.378 0.269 0.2 0.2780.065 0.148 0.409 Design #3 0.381 0.275 0.188 0.28 0.076 0.128 0.431Design #4 0.409 0.277 0.184 0.288 0.089 0.11 0.466 Design #5 0.415 0.2760.169 0.284 0.093 0.098 0.469 Reference 0.232 0.192 0.145 0.19 0.0330.124 0.256

The average MTF initially increases with an increase in the asphericalcorrection exhibited by the lens designs to reach a plateau, and thendeclines. In fact, the design option providing a substantially completespherical aberration correction does not provide the best overalloptical performance across the whole population. Rather, the average MTFpeaks when the lens partially corrects the corneal spherical aberration.The spread of optical performance within the simulated population alsoincreases as the amount of spherical aberration correction provided bythe lens designs increases. In particular, an increase in the amount ofspherical aberration correction results in over-correction for anincreasing percentage of the population while providing benefits formore patients with aberrated corneas. Regardless, all of the asphericaldesign options (#1 to #5) provide considerable advantages over thespherical reference design.

FIG. 12 graphically depicts a change in the MTF associated with eachsimulated eye in response to replacing the spherical reference lens withone of the aspherical lenses. The percentage of eye models (simulatedpatients) that benefit from an aspherical design can be calculated bycounting the number of eye models that exhibit an improvement in theirrespective MTFs. The aspherical designs generally exhibit an improvedoptical performance relative to the spherical design for the majority ofthe eye models. For example, the percentage of the eye models thatbenefit from the design options #1 through #5 in the above simulationsranges from about 84% to about 90%, with the design options #1 through#3 providing the more pronounced improvements.

Similar Monte Carlo simulations were performed for the abovehypothetical lenses for an entrance pupil size of 4.5 mm. As in theprevious simulations, 200 eye models were considered for each lensdesign option. Table 3 below lists the results of these simulations interms of average MTF, the 10, 50 and 90 percentiles, as well as standarddeviation (SD) and ±2 SD deviations from the mean:

TABLE 3 Mean − 10% 50% 90% Mean Std 2 * Std Mean + 2 * Std Design #10.413 0.342 0.263 0.342 0.06 0.222 0.504 Design #2 0.46 0.363 0.2610.356 0.072 0.212 0.496 Design #3 0.47 0.355 0.265 0.362 0.079 0.2040.486 Design #4 0.473 0.336 0.242 0.345 0.089 0.167 0.423 Design #50.439 0.332 0.228 0.332 0.079 0.174 0.427 Reference 0.307 0.25 0.1660.243 0.054 0.136 0.325

FIG. 13 shows the distribution of the MTF values corresponding todifferent simulated eye models in which the above lens options wereincorporated. Further, Table 4 below provides a summary of MTFimprovement and percentage of simulated eyes benefiting from eachaspherical design relative to the spherical reference lens:

TABLE 4 4.5 mm pupil 6.0 mm pupil % % of % % of (log) benefited (log)benefited improvement population improvement population Design #1 41%83% 28% 87% Design #2 47% 85% 47% 90% Design #3 49% 89% 47% 86% Design#4 42% 87% 52% 86% Design #5 37% 85% 49% 84%

These simulations suggest that Design #3 provides the best averageoptical performance, with the maximum percentage of simulated patientsatisfaction (as measured by the MTF). In particular, the average MTFassociated with Design #3 is greater by about 0.17 log unit relative tothat of the reference lens, with up to about 89% of the simulated eyemodels exhibiting better performance with Design #3 than with thereference lens.

In some embodiments, the simulations of the model eyes can be utilizedto select one or more lens Designs as providing the best fit for apopulation of interest, for example, based on the average MTF computedfor the simulated eyes and/or the percentage of simulated eyes thatexhibit improved performance relative to a reference. For example, theabove simulations for a 4 mm pupil can be utilized to select Designoptions #2, #3 and #4 as providing a greater average MTF as well as ahigher percentage of simulated eyes exhibiting improved performancerelative to the reference lens. For the simulations employing a 6 mmpupil size, the Design options #3, #4, and #5 can be selected based onMTF improvement and Design options #1, #2 and #3 can be selected basedon increase in percentage of the simulated eyes exhibiting improvedperformance. In all cases, the Design option #3 provides superioroptical performance and spherical correction robustness.

In some embodiments, a family of IOL designs can be selected, based onevaluation of the optical performance of a plurality of IOL designs,such that each selected IOL design provides the best fit visualperformance (e.g., visual acuity, contrast sensitivity or a combinationthereof) for a portion of a population of patient eyes. By way ofexample, an IOL design exhibiting an spherical aberration of about −0.1microns can be selected for patients within one portion of thepopulation while two other IOL designs, one exhibiting an sphericalaberrations of about −0.2 micron and the other exhibiting an sphericalaberration of about −0.3 microns, can be selected for two other portionsof the population.

The visual performance of an IOL can be evaluated based on anyappropriate criterion (e.g., based on visual acuity, contrastsensitivity or a combination of the two). In some embodiments, theoptical performance of an IOL design is modeled (evaluated) by utilizingMTF values at low spatial frequencies to model contrast sensitivityobtained by that IOL and employing MTF values at high spatialfrequencies to model visual acuity obtained by that IOL. By way ofexample, spatial frequencies less than about 60 lp/mm (˜18cycles/degree) (e.g., in a range of about 5 to about 60 lp/mm (˜1.5 to18 cycles/degree)) can be employed to evaluate contrast sensitivityexhibited by a model eye in which an IOL design is incorporated whilespatial frequencies greater than about 60 lp/mm (˜18 cycles/degree)(e.g. in a range of about 60 to about 100 lp/mm (˜18 to 30cycles/degree)) can be employed to evaluate visual acuity exhibited bythat model eye.

In some embodiments, manufacturing tolerances can be considered insimulating the performance of an IOL in a model eye. By way of example,manufacturing tolerances corresponding to lens surface radius andasphericity, lens surface irregularity, lens surface centration andtilt, lens thickness and toric tolerance can be taken into account todetermine an optimal IOL for implantation in eyes of patients within apopulation of interest. For example, in Monte Carlo simulations, one ormore of such tolerances (e.g., in addition to the biometric parametersdiscussed above) can be varied over a range typically observed inmanufacturing of a lens of interest so as to model their contributionsto the performance of one or more lens designs. The lens designexhibiting the best performance can then be selected as the mostsuitable for use in the population of interest.

When an IOL is implanted in a patient's eye, the IOL's optical axis canbe offset (e.g., due to tilt and/or decentration) relative to an axisassociated with the eye's line of sight. Hence, in some embodiments, theeffects of such offset are considered in simulating the performance of aplurality of IOLs incorporated in model eyes. By way of example, asshown schematically in FIG. 14, the line of sight of an eye model 26 canbe associated with a set of rays 28 that are offset relative to a set ofrays 30 incident on an IOL 32, which is incorporated in the model eye,parallel to the IOL's optical axis.

By way of illustration, FIGS. 15A and 15B compare the opticalperformance of two lenses, one having an aspherical surface and theother spherical surfaces, incorporated in an average model eye as afunction of a 5-degree tilt relative to the eye's line of sight. Morespecifically, FIG. 15A presents polychromatic (incident light havingwavelengths of 450 nm, 550 nm, and 650 nm) MTF curves 34, 36 and 38,calculated at the retinal plane of the model eye with a 5-mm pupil inwhich the aspherical lens having a surface asphericity characterized bya conic constant of about −42 was incorporated. The curve 34 correspondsto zero tilt, while the curves 36 and 38, in turn, provide MTF valuesalong two orthogonal directions for a case in which the optical axis ofthe lens is tilted by about 5-degrees relative to the line of sightassociated with the model eye. FIG. 15B also provides threepolychromatic MTF curves 40, 42, and 44, where the curve 40 correspondsto zero tilt between the optical axis of the spherical lens relative tothe eye's line of sight while the curves 42 and 44 provide MTF valuesalong two orthogonal directions for a case in which the optical axis ofthe IOL exhibits a 5-degree tilt relative to the eye's line of sight. Acomparison of the MTF curves presented by FIGS. 15A and 15B indicatesthat although the tilt can have a greater affect on the performance ofthe aspherical IOL, the aspherical IOL provides a considerably enhancedcontrast relative to the spherical IOL.

The offset of an IOL's optical axis relative to a patient's eye line ofsight can be due not only to a tilt but also a decentration of the IOL.By way of illustration, FIG. 16A presents respective polychromatic MTFcurves 46, 48, and 50 calculated at the retina of an average model eyewith a 5-mm pupil in which an aspherical IOL, characterized by a conicconstant of about −27, was incorporated. The curve 46 is a reference MTFcorresponding to zero tilt and decentration while curves 48 and 50present MTF values along two orthogonal directions corresponding to a5-degree tilt and a 0.5-mm displacement of the IOL's optical axisrelative to the pupil's center. FIG. 16B presents, in turn, MTF curves52, 54, 56 and 58 calculated at the retina of an average model eye inwhich a spherical IOL was incorporated. The curves 52 and 54 arereference MTFs corresponding to zero tilt and decentration of the IOL'soptical axis relative to the model eye's line of sight while the curves56 and 58 provide MTF values along two orthogonal directionscorresponding to a 5-degree tilt and a 0.5-mm decentration. (i.e., adisplacement of the optical axis of the IOL relative to the center ofthe pupil). A comparison of the MTFs presented in FIGS. 16A and 16Bindicates that the aspherical IOL provides a better optical performancethan the spherical IOL for the assumed tilt and decentration values.

More generally, in many embodiments of the invention, an asphericitycharacterized by a conic constant in a range of about −73 to about −27can be imparted to at least one surface of the IOL to ensure a morerobust performance in presence of an offset of the line of sightrelative to an optical axis of an IOL. By way of example, a mostsuitable value of the asphericity for a patient population can beobtained, e.g., by evaluating optical performance of lenses withdifferent values of asphericity (e.g., by performing Monte Carlosimulations) for a range of typically observed offset values.

Those having ordinary skill in the art will appreciate that variouschanges can be made to the above embodiments without departing from thescope of the invention.

1. An intraocular lens (IOL) manufactured by the method of: establishingat least one eye model in which the ocular parameter can be varied overa range exhibited by the population, employing the eye model to evaluatea plurality of IOL designs for visual performance for eyes in thepatient population, applying a weighting function to visual performanceexhibited by the plurality of IOL designs, said function being based ondistribution of the ocular parameter in the population, selecting an IOLdesign that provides a best fit for visual performance over at least aportion of the range exhibited by the population; and manufacturing atleast one IOL according to the selected IOL design.
 2. The method ofclaim 1, wherein said visual performance comprises visual acuity.
 3. Themethod of claim 2, further comprising determining the best fit forvisual acuity as an optimal value of a weighted visual acuity among theIOL designs.
 4. The method of claim 2, further comprising determining amodulation transfer function at the retina of the eye model forobtaining the visual acuity exhibited by the plurality of IOL designs.5. The method of claim 1, further comprising generating said pluralityof IOL designs based on varying at least one lens design parameter. 6.The method of claim 1, wherein said ocular parameter comprises ocularaxial length.
 7. The method of claim 1, wherein said ocular parametercomprises corneal asphericity.
 8. The method of claim 1, wherein saidocular parameter comprises corneal radius.
 9. The method of claim 1,wherein said ocular parameter comprises ocular anterior chamber depth.10. An intraocular lens (IOL) manufactured by the process of: generatinga human eye model in which at least one ocular biometric parameter canbe varied, evaluating optical performance of a plurality of IOL designsby incorporating the designs in the eye model and varying said ocularparameter over at least a portion of a range exhibited by eyes in apatient population, and applying a weighting function to visualperformance exhibited by the plurality of IOL designs, said functionbeing based on distribution of the ocular parameter in the population,selecting one of the IOL designs that provides a desirable level ofperformance; and manufacturing at least one IOL according to theselected IOL design.
 11. The method of claim 10, wherein said ocularparameter comprises any of corneal radius, corneal asphericity, anteriorchamber depth or ocular axial length.
 12. The method of claim 10,further comprising generating said IOL designs by varying at least onelens design parameter.
 13. The method of claim 12, wherein said lensdesign parameter comprises any of a conic constant of an aspherical lenssurface, two conic constants associated with a toric lens surface or anapodization function associated with step heights at zone boundaries ofa diffractive pattern disposed on a lens surface.
 14. The method ofclaim 10, wherein the step of evaluating optical performance of theplurality of IOL designs further comprises employing the eye model todetermine an average visual acuity provided by that design over saidocular parameter range.
 15. The method of claim 14, further comprisingcalculating a modulation transfer function at the retina of the eyemodel for determining said visual acuity.
 16. The method of claim 10,further comprising identifying the IOL design of the plurality of IOLdesigns that exhibits the largest weighted average visual acuity asproviding an optimal performance.
 17. The method of claim 10, furthercomprising utilizing Monte Carlo simulation for varying said ocularparameter.
 18. The method of claim 10, further comprising incorporatingan estimate of manufacturing tolerance associated with at least one lenscharacteristic into the plurality of IOL designs
 19. The method of claim18, wherein said lens characteristic comprises irregularities associatedwith a lens surface.
 20. The method of claim 18, wherein said lenscharacteristic comprises a radius of a lens surface.
 21. The method ofclaim 18, wherein said lens characteristic comprises an asphericity of alens surface.
 22. The method of claim 18, wherein said lenscharacteristic comprises lens thickness.